FDA 510(k)

Shape-HF Cardiopulmonary Testing System

Número K: K150888 · 2016-01-21

Data da decisão2016-01-21

Código do produtoBTY

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shape-HF Cardiopulmonary Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Shape Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K150888. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Shape-HF Cardiopulmonary Testing System?

Shape-HF Cardiopulmonary Testing System is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Shape Medical Systems, Inc.. The 510(k) number is K150888.

When did Shape-HF Cardiopulmonary Testing System receive FDA 510(k) clearance?

Shape-HF Cardiopulmonary Testing System received FDA 510(k) clearance on 2016-01-21, under 510(k) number K150888.

Who is the listed applicant for Shape-HF Cardiopulmonary Testing System?

The FDA 510(k) record lists Shape Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shape-HF Cardiopulmonary Testing System?

The FDA product code for Shape-HF Cardiopulmonary Testing System is BTY.

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